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KYPROLIS Drug Profile

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Which patents cover Kyprolis, and what generic alternatives are available?

Kyprolis is a drug marketed by Onyx Therap and is included in one NDA. There are eleven patents protecting this drug and three Paragraph IV challenges.

This drug has two hundred and thirteen patent family members in forty countries.

The generic ingredient in KYPROLIS is carfilzomib. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the carfilzomib profile page.

US ANDA Litigation and Generic Entry Outlook for Kyprolis

A generic version of KYPROLIS was approved as carfilzomib by DR REDDYS on January 24^th, 2020.

Summary for KYPROLIS

International Patents:	213
US Patents:	11
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	60
Clinical Trials:	65
Patent Applications:	224
Drug Prices:	Drug price information for KYPROLIS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KYPROLIS
DailyMed Link:	KYPROLIS at DailyMed

See drug prices for KYPROLIS

Recent Clinical Trials for KYPROLIS

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Andrew Yee, MD	Phase 2
Janssen Research & Development, LLC	Phase 2
Amgen	Phase 4

See all KYPROLIS clinical trials

Recent Litigation for KYPROLIS

Identify potential future generic entrants

District Court Litigation

Case Name	Date
CyDex Pharmaceuticals, Inc. v. Alembic Global Holding SA	2019-05-23
Onyx Therapeutics, Inc. v. Breckenridge Pharmaceutical, Inc.	2019-01-11
Onyx Therapeutics, Inc. v. CIPLA Limited	2018-04-20

See all KYPROLIS litigation

Pharmacology for KYPROLIS

Drug Class	Proteasome Inhibitor
Mechanism of Action	Proteasome Inhibitors

Synonyms for KYPROLIS

(2S)-4-methyl-N-[(2S)-1-[[(2S)-4-methyl-1-[(2R)-2-methyloxiran-2-yl]-1-oxopentan-2-yl]amino]-1-oxo-3-phenylpropan-2-yl]-2-[[(2S)-2-[(2-morpholin-4-ylacetyl)amino]-4-phenylbutanoyl]amino]pentanamide

(2S)-N-((1S)-1-Benzyl-2-(((1S)-3-methyl-1-(((2R)-2-methyloxiran-2-yl)carbonyl)butyl)amino)-2-oxoethyl)-4-methyl-2-(((2S)-2-((morpholin-4-ylacetyl)amino)-4-phenylbutanoyl)amino)pentanamide

(2S)-N-[(1S)-1-benzyl-2-[[(1S)-3-methyl-1-[(2R)-2-methyloxirane-2-carbonyl]butyl]amino]-2-oxo-ethyl]-4-methyl-2-[[(2S)-2-[(2-morpholinoacetyl)amino]-4-phenyl-butanoyl]amino]pentanamide

(Alphas)-alpha-((4-morpholinylacetyl)amino)benzenebutanoyl-l-leucyl-n-((1s)-3-methyl-1-(((2r)-2-methyloxiranyl)carbonyl)butyl)-l-phe nylalaninamide

(alphas)-alpha-((4-morpholinylacetyl)amino)benzenebutanoyl-l-leucyl-n-((1s)-3-methyl-1-(((2r)-2-methyloxiranyl)carbonyl)butyl)-l-phenylalaninamide

(alphaS)-alpha-[[2-(4-Morpholinyl)acetyl]amino]benzenebutanoyl-L-leucyl-N-[(1S)-3-methyl-1-[[(2R)-2-methyl-2-oxiranyl]carbonyl]butyl]-L-phenylalaninamide

(S)-4-methyl-N-((S)-1-(((S)-4-methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopentan-2-yl)amino)-1-oxo-3-phenylpropan-2-yl)-2-((S)-2-(2-morpholinoacetamido)-4-phenylbutanamido)pentanamide

(S)-4-Methyl-N-((S)-1-((S)-4-Methyl-1-((R)-2- Methyloxiran-2-yl)-1 -oxopentan-2-ylaMino)-1-oxo-3-phenylpropan-2-yl)-2-((S)-2-(2-MorpholinoacetaMido)-4-phenylbutanaMido)pentanaMide

72X6E3J5AR

868540-17-4

AB0008111

AB01565867_02

AC-27051

AK546882

AKOS025401910

AN-217

AOB87759

AS-17059

BC251806

BDBM50277889

BLMPQMFVWMYDKT-NZTKNTHTSA-N

C40H57N5O7

Carfilzomib

Carfilzomib (JAN/USAN/INN)

Carfilzomib (PR-171)

Carfilzomib [USAN:INN]

Carfilzomib; PR171

Carfilzomib?PR-171?/Kyprolis

Carfilzomib(PR171)

CAS-868540-17-4

CHEBI:65347

CHEMBL451887

CS-0984

CS-W004540

D08880

DB08889

DSSTox_CID_28616

DSSTox_GSID_48690

DSSTox_RID_82886

DTXSID4048690

EX-A2037

FT-0696769

GTPL7420

HY-10455

J-501773

KB-75946

KS-00000SR1

Kyprolis (TN)

L-Phenylalaninamide, (alphaS)-alpha-((4-morpholinylacetyl)amino)benzenebutanoyl-L-leucyl-N-((1S)-3-methyl-1-(((2R)-2-methyloxiranyl)carbonyl)butyl)-

MLS006011102

MolPort-027-950-907

N-{(2S)-2-[(morpholin-4-ylacetyl)amino]-4-phenylbutanoyl}-L-leucyl-N-{(2S)-4-methyl-1-[(2R)-2-methyloxiran-2-yl]-1-oxopentan-2-yl}-L-phenylalaninamide

NCGC00249613-01

NCGC00249613-02

NCGC00249613-03

ONO-7057

PR-171

PX-171-007

QCR-96

RL05381

S-7798

s2853

SB16813

SC-91032

SCHEMBL85165

SMR004660024

SR-01000941582

SR-01000941582-1

SW218090-2

Tox21_113079

Tox21_113079_1

UNII-72X6E3J5AR

Y0441

ZINC49841054

Paragraph IV (Patent) Challenges for KYPROLIS

Tradename	Dosage	Ingredient	NDA	Submissiondate
KYPROLIS	POWDER;INTRAVENOUS	carfilzomib	202714	2018-11-28
KYPROLIS	POWDER;INTRAVENOUS	carfilzomib	202714	2017-10-05
KYPROLIS	POWDER;INTRAVENOUS	carfilzomib	202714	2016-07-20

US Patents and Regulatory Information for KYPROLIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Onyx Therap	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012	AP	RX	Yes	Yes			Y
Onyx Therap	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012	AP	RX	Yes	Yes
Onyx Therap	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012	AP	RX	Yes	Yes

International Patents for KYPROLIS

Country	Patent Number	Estimated Expiration
Cyprus	1116771
Ecuador	SP11011027
Lithuania	3101026

Supplementary Protection Certificates for KYPROLIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1781688	CR 2016 00014	Denmark		PRODUCT NAME: CARFILZOMIB OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/15/1060 20151123
1781688	CA 2016 00014	Denmark		PRODUCT NAME: CARFILZOMIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/15/1060 20151123
1781688	122016000032	Germany		PRODUCT NAME: CARFILZOMIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1060 20151119